BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RX STREAK

    MDR report key: 9272 · Received July 29, 1994

    Report

    Report Number
    9272
    Event Type
    Malfunction
    Date Received
    July 29, 1994
    Report Date
    July 11, 1994
    Manufacturer
    ACS
    Product Code
    GBA
    Product Problem
    Yes
    Report Source
    User Facility report

    Narratives

    Description of Event or Problem · 1

    BALLOON CATHETER RUPTURED 1-1 1/2" PROXIMAL TO BALLOON. BALLOON ITSELF DID NOT RUPTURE.INVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE. PATIENT MEDICAL STATUS PRIOR TO EVENT: INVALID DATA. INVALID DATA - REGARDING MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE. NO DATA - REGARDING DATE LAST SERVICED. SERVICE PROVIDED BY: INVALID DATA. INVALID DATA - SERVICE RECORDS AVAILABILITY.INVALID DATA - REGARDING WHETHER EVENT PRESENTS IMMINENT HAZARD. INVALID DATA - WHETHER DEVICE USED AS LABELED/INTENDED.DEVICE WAS NOT EVALUATED AFTER THE EVENT. METHOD OF EVALUATION: NO DATA. RESULTS OF EVALUATION: NO DATA. CONCLUSION: NO DATA. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: INVALID DATA. CORRECTIVE ACTIONS: NO DATA. INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RX STREAK BALLOON CATHETER GBA ACS 014-2.25 3060751

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other